Evaluation of a Non-invasive Brain Compliance Measurement Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Unique signal measured in Hertz
研究概览
简要总结
This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.
详细描述
At enrollment, 1 week, 1 month, 3 month, 12 month Computerized neurocognitive testing Wear NNS
MRI of the brain at 3 month and 12 months
Formal neurocognitive testing at 3 months and 12 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for the study, all subjects must meet the following criteria:
- •Healthy control OR
- •Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines
- •Age 10 years to less than 17 years
- •Parent/guardian understand the study protocol and agrees to comply with it.
- •Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English.
排除标准
- •Subjects who meet any of the following criteria are not eligible for the study:
- •History of head trauma with any loss of consciousness
- •History of premature birth (less than 30 weeks of gestation)
- •History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age
- •History of neurologic disease independent of diabetes (seizure disorder)
结局指标
主要结局
Unique signal measured in Hertz
时间窗: 3 months
We will be using the brain compliance measurement device to see if there is a unique signal for those with DKA and if so, follow the duration of this signal.
次要结局
未报告次要终点
研究者
Tandy Aye
Assistant Professor
Stanford University